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Month: March 2022

Intra-Cellular Therapies Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Corporate Update

Received FDA approval for CAPLYTA® (lumateperone) for the treatment of bipolar depression in adults.CAPLYTA is the first and only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.Total revenues for the fourth quarter were $25.7 million, compared to $12.5 million for the same period in 2020, representing a 106% increase. Total revenues for the year were $83.8 million, compared to $22.8 million in 2020, representing a 267% increase. Achieved CAPLYTA net product revenues of $25.5 million for the fourth quarter representing a 106% increase over the same period in 2020 and an 18% increase over the prior quarter. For the full year, CAPLYTA net revenues were $81.7 million, compared to $22.5 million in...

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Minerva Neurosciences Reports Fourth Quarter 2021 Financial Results and Business Updates

WALTHAM, Mass., March 01, 2022 (GLOBE NEWSWIRE) — Minerva Neurosciences, Inc. (NASDAQ: NERV) a clinical-stage biopharmaceutical company focused on the development of innovative therapies to treat central nervous system disorders, today reported key business updates and financial results for the fourth quarter ended December 31, 2021. The Company is not hosting a call this quarter as it prepares for a meeting with the FDA and anticipates providing an update after the meeting, as appropriate. Corporate Updates “During 2021, we advanced our roluperidone program towards the potential filing of a New Drug Application (NDA) by completing several important development activities, including our 40-week Phase 3 Open Label Extension (OLE) and our pivotal bioequivalence study. In addition, we strengthened our financial position by selling...

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Cronos Group Reports 2021 Fourth Quarter and Full-Year Results

Consolidated net revenue increased 59% in Full Year 2021 compared to Full Year 2020 Announces the planned exit of its Peace Naturals Campus in Stayner, Ontario to streamline supply chain and improve profitability TORONTO, March 01, 2022 (GLOBE NEWSWIRE) — Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos Group” or the “Company”), today announces its 2021 fourth quarter and full-year business results. “I am proud of the dedication and resilience our team has shown throughout the past year as we navigated through a dynamic market environment,” said Kurt Schmidt, President and CEO, Cronos Group. “Our fourth quarter 2021 results indicate positive momentum, which we will look to carry forward as we begin to implement our strategic and operational realignment initiatives. As we look to 2022, we will continue to realign Cronos Group’s...

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PMV Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights

Continued progress with Phase 1/2 study of PC14586, a first-in-class precision oncology investigational therapy in patients with advanced solid tumors that have a p53 Y220C mutation Strong cash, cash equivalents and marketable securities of $314.1 million as of December 31, 2021CRANBURY, N.J., March 01, 2022 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the fourth quarter and full year ended December 31, 2021 and provided corporate highlights. “We expect that 2022 will be another productive year for PMV Pharma, following accomplishments across multiple fronts in 2021,” said David Mack, Ph.D., President and Chief Executive Officer. “We are encouraged...

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Achilles Therapeutics Reports Fourth Quarter and Year-End 2021 Financial Results and Recent Business Highlights

– Patient data from higher dose cNeT as monotherapy and cNeT in combination with checkpoint inhibitor expected in 2H 2022 – – Strong cash position of $266 million supports clinical development and manufacturing expansion into 2H 2024 – LONDON, March 01, 2022 (GLOBE NEWSWIRE) — Achilles Therapeutics plc (NASDAQ: ACHL), a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, today announced its financial results for the fourth quarter and year-ended December 31, 2021, and recent business highlights. “In 2021, we generated clinical data demonstrating the unique ability of our T cell platform to detect, quantify and track our clonal neoantigen-reactive T cells, or cNeT, in vivo, giving us the analytical platform to elucidate the mechanism of action of our cNeT...

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iTeos to Present at the Cowen 42nd Annual Health Care Conference

CAMBRIDGE, Mass. and GOSSELIES, Belgium, March 01, 2022 (GLOBE NEWSWIRE) — iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, today announced that Michel Detheux, Ph.D., President and Chief Executive Officer, will present at the Cowen 42nd Annual Health Care Conference on Tuesday, March 8, 2022 at 12:50 p.m. ET. A live webcast of the virtual presentation will be available on the Investors section of the company’s website at https://www.iteostherapeutics.com. An archived replay will be available for approximately 30 days following the presentation. About iTeos Therapeutics, Inc.iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and...

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EyePoint Pharmaceuticals to Participate in Fireside Chat at the Cowen 42nd Annual Health Care Conference

WATERTOWN, Mass., March 01, 2022 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced that Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals, will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on Tuesday, March 8, 2022 at 10:30 a.m. ET. A live webcast and subsequent archived replay of the fireside chat may be accessed via the Investors section of the Company website at www.eyepointpharma.com. The replay will be available for 90 days after the event. About EyePoint Pharmaceuticals EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical company committed to developing and commercializing therapeutics to help...

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ZimVie Completes Separation from Zimmer Biomet; Announces Board of Directors

WESTMINSTER, Colo., March 01, 2022 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV) today announced its debut as an independent publicly traded company and the completion of its separation from Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH). This separation completes the path ZimVie began in 2021 when its former parent company announced its intention to separate its Dental and Spine businesses into one of the world’s newest and leading life sciences companies. ZimVie common stock began “regular way” trading under the symbol “ZIMV” on the Nasdaq Stock Market. “As an independent company, we are uniquely poised to expand the reach of our Dental and Spine product platforms through innovation and enhanced commercial and operational focus,” said Vafa Jamali, President and Chief Executive Officer of ZimVie. “Our solutions hold strong positions...

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Bioventus Receives 510(k) Clearance for StimRouter Pain Management Device

Industry Leading Peripheral Nerve Stimulator Upgraded to Improve Patient User Experience with Control of their Unique Chronic Pain Condition, Longer Battery Life DURHAM, N.C., March 01, 2022 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced that the US Food and Drug Administration (FDA) has awarded 510(k) clearance to the next generation StimRouter® Neuromodulation System for the treatment of chronic pain of peripheral nerve origin, excluding craniofacial pain. StimRouter is a minimally invasive neuromodulation medical device consisting of a thin, implanted lead with conductive electrode, external electric field conductor (E-EFC), and StimRouter Plus Mobile Application. Electrical signals are transmitted transcutaneously from the E-EFC and...

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Acceleware Announces Non-Brokered Private Placement of 10% Unsecured Convertible Debentures

NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR DISSEMINATION IN THE U.S. CALGARY, Alberta, March 01, 2022 (GLOBE NEWSWIRE) — Acceleware Ltd. (“Acceleware”) (TSXV: AXE), a Canadian clean-tech innovator of radio frequency (RF) heating technologies today announced that it is launching a non-brokered private placement of 10% unsecured convertible debentures due 2026 (the “Debentures”), for approximate gross proceeds of $1,500,000 (the “Private Placement”). Details of the Private Placement Each Debenture matures four years after the issue date and is convertible into units of Acceleware at a conversion price of $0.80. If Acceleware subsequently sells common shares (or securities that are convertible into or exchangeable for common shares) at a lower purchase (or conversion) price, the conversion price of the Debentures will be adjusted...

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